BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US MEDCO INC

    MDR report key: 7561888 · Received June 1, 2018

    Report

    Report Number
    1047429-2018-00003
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 1, 2018
    Manufacturer
    US MEDCO, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) CONCERNING THE LAP SPONGE THAT MALFUNCTIONED DURING USE WHEN THE LOOP SEPARATED FROM THE SPONGE AND HAD TO BE RETRIEVED FROM INSIDE THE PATIENT. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR INSPECTION BY THE MANUFACTURER.

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT INCLUDES THE FOLLOWING COMPONENT: LAP SPONGE 18X18 XR 5S NO RING, VENDOR PART # 1818W1900 MANUFACTURED BY US MEDCO INC. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2018 ORIGINATED BY (B)(4), SUPPLY CHAIN MANAGEMENT AT(B)(6) STATING THAT THE LOOP FROM THE SPONGE CAME OFF INSIDE THE PATIENT. THE LOOP AND SPONGE WERE RETRIEVED FOLLOWING AN X-RAY, ADDITIONAL EXPLORATION AND FLUSHING WITH SALINE. THIS INCIDENT CAUSED A DELAY IN SURGERY. THE COMPLAINED LAP SPONGE 18X18 XR 5S NO RING WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, A PHOTOGRAPH WAS PROVIDED BY THE HOSPITAL. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER US MEDCO INC CONCERNING THE LOOP FALLING OFF THE LAP SPONGE AND INTO THE PATIENT FOR ITEM NO. 1818W1900, MANUFACTURER LOT# 35-17. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405943 US MEDCO INC LAP SPONGE NON ABSORBABLE GDY US MEDCO, INC. 35-17

    Patients

    Seq Age Sex Outcome Treatment
    1